The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for August 2018 (PDF).
This issue advises of the risk of serious liver injury and new restrictions introduced for ulipristal acetate (Esmya®). It is now recommended that treatment is initiated and supervised by physicians experienced in the diagnosis and treatment of uterine fibroid for:
- the intermittent treatment of moderate to severe symptoms of uterine fibroids in women of reproductive age who are not eligible for surgery
- one treatment course of pre-operative treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age
It is also contraindicated in women with underlying liver disorders and regular liver function monitoring during and immediately after treatment is recommended.
Finally this month, the summary of letters to healthcare professionals includes further information about pregnancy prevention programme materials to support safe use of valproate containing medicines in girls and women of child bearing potential.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.
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